LEFLUNOMIDE MEDAC 10 mg FILM-COATED TABLETS

2. What you need to know before you take Leflunomide medac

Do not take Leflunomide medac

• if you have ever had an allergic reactionto leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red spots on the skin, or blisters, e.g., Stevens-Johnson syndrome), to peanuts or soy, or to any of the other ingredients of this medicine (listed in section 6), or if you are allergic to teriflunomide (used to treat multiple sclerosis).
• if you have any liver problems,
• if you have kidney problemsof moderate to severe degree,
• if you have a severe decrease in blood protein levels(hypoproteinemia),
• if you have any immune system problems(e.g., AIDS),
• if you have any bone marrow problemsor if you have a reduced number of red or white blood cells or platelets in your blood,
• if you have a severe infection,
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Leflunomide medac

• if you have ever had lung inflammation(interstitial lung disease),
• if you have ever had tuberculosisor if you have been in close contact with someone who has or has had tuberculosis. Your doctor may perform tests to see if you have tuberculosis,
• if you are a maleand wish to have children. As it cannot be excluded that Leflunomide medac passes into semen, reliable contraceptive methods should be used during treatment with Leflunomide medac. Men who wish to have children should contact their doctor, who may advise them to discontinue treatment with Leflunomide medac and take certain medications to rapidly and sufficiently eliminate Leflunomide medac from their body. In this case, a blood test will be necessary to ensure that Leflunomide medac has been sufficiently eliminated from their body, and then they should wait at least 3 months before trying to have children.
• if you are scheduled to have a specific blood test (calcium level). A false decrease in calcium levels may be detected.
• if you are going to undergo or have recently undergone major surgery, or if you still have an unhealed wound after surgery. Leflunomide medac may impair wound healing.

Occasionally, Leflunomide medac may cause some blood, liver, lung, or nerve problems in the arms or legs. It may also cause some severe allergic reactions (including drug rash with eosinophilia and systemic symptoms [DRESS]), or increase the risk of serious infections. For more information on these side effects, see section 4 (Possible side effects).

DRESS initially appears with symptoms similar to those of the flu and a skin rash on the face, followed by a widespread skin rash with fever, elevated liver enzyme levels in the blood, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

Your doctor will perform blood testsat regular intervals, before and during treatment with Leflunomide medac, to monitor blood cells and liver function. Your doctor should also regularly check your blood pressure, as Leflunomide medac may cause an increase in blood pressure.

Consult your doctor if you experience chronic diarrhea of unknown origin. You may need to undergo additional tests to establish a differential diagnosis.

Inform your doctor if you develop a skin ulcer during treatment with Leflunomide medac (see section 4).

Children and adolescents

Leflunomide medac is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Leflunomide medac

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription.

This is especially important if you are taking:

• other medicines for rheumatoid arthritissuch as antimalarials (e.g., chloroquine and hydroxychloroquine), gold salts by intramuscular or oral route, D-penicillamine, azathioprine, and other immunosuppressive agents (e.g., methotrexate), as these combinations are not recommended.
• warfarin (used as a blood anticoagulant), as monitoring is required to reduce the risk of adverse effects of this medicine
• teriflunomide for multiple sclerosis
• repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
• duloxetine for depression, urinary incontinence, or renal insufficiency in diabetics
• alosetron for severe diarrhea
• theophylline for asthma
• tizanidine, a muscle relaxant
• oral contraceptives (containing ethinylestradiol and levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
• indomethacin, ketoprofen for pain or inflammation
• furosemide for heart disease (diuretic, water pills)
• zidovudine for HIV infection
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• a medicine called cholestyramine (used to reduce high cholesterol)or activated charcoal, as these medicines may reduce the amount of Leflunomide medac absorbed by the body.

If you are taking a non-steroidal anti-inflammatory drug (NSAID)and/or corticosteroids, you may continue taking them after starting treatment with Leflunomide medac.

Vaccinations

Consult your doctor if you need to be vaccinated. Some vaccines may not be given while you are being treated with Leflunomide medac or for a certain period after stopping treatment.

Taking Leflunomide medac with food, drink, and alcohol

Leflunomide medac can be taken with or without food.

Do notdrink alcohol during treatment with Leflunomide medac. Consuming alcohol during treatment with Leflunomide medac may increase the risk of liver damage.

Pregnancy and breastfeeding

Do nottake Leflunomide medac if you are or think you may be pregnant. If you are pregnant or become pregnant while taking Leflunomide medac, there is an increased risk of having a child with serious birth defects. Women of childbearing age must not take Leflunomide medac without using reliable contraceptive measures.

Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide medac, as it is necessary to ensure that there are no remaining levels of Leflunomide medac in your body before becoming pregnant. The elimination of the medicine from the body may take up to 2 years. This time period can be reduced to a few weeks by taking certain medicines that accelerate the elimination of Leflunomide medac from the body. In any case, before becoming pregnant, a blood test will be necessary to confirm that Leflunomide medac has been sufficiently eliminated from your body, and once this test has been performed, you should wait at least 1 month before becoming pregnant.

For more information on laboratory tests, contact your doctor.

If you suspect that you may be pregnant during treatment with Leflunomide medac or in the 2 years after treatment, you should immediatelycontact your doctor for a pregnancy test. If the test confirms that you are pregnant, your doctor may suggest that you start treatment with certain medicines to rapidly and sufficiently eliminate Leflunomide medac from your body, thereby reducing the risk to your child.

Do nottake Leflunomide medac while breastfeeding, as leflunomide passes into breast milk.

Driving and using machines

Leflunomide medac may make you feel dizzy, which may affect your ability to concentrate and react. If this happens, do not drive or use machines.

Leflunomide medac contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Leflunomide medac contains soy lecithin

Do not use the medicine if you are allergic to peanuts or soy.

Leflunomide medac contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Leflunomide medac

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The usual initial dose of Leflunomide medac is 100 mg of leflunomide once daily for the first three days. After this, most people need a dose of:

• For rheumatoid arthritis: 10 mg or 20 mg of Leflunomide medac once daily, depending on the severity of the disease.
• For psoriatic arthritis: 20 mg of Leflunomide medac once daily.

Swallowthe tablet wholeand with plenty of water.

It may take about 4 weeks or even longer before you start to feel better. Some patients may even notice improvement after 4 or 6 months of treatment. In general, Leflunomide medac should be taken for prolonged periods.

If you take more Leflunomide medac than you should

If you take more Leflunomide medac than you should, consult your doctor or any other healthcare service. If possible, take the tablets or the box with you to show the doctor.

If you forget to take Leflunomide medac

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop taking Leflunomide medac:

• if you feel weak, dizzy, or lightheaded, or have difficulty breathing, as these may be symptoms of a severe allergic reaction,
• if you develop skin rashes or mouth ulcers, as these may indicate severe reactions that can be life-threatening (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic symptoms [DRESS]), see section 2.

Tell your doctor immediatelyif you experience:

• pale skin, tiredness, or bruising, as these may indicate blood problems caused by an imbalance in the different types of cells that make up the blood,
• tiredness, abdominal pain, or yellowing of the skin or eyes(jaundice), as these may indicate serious problems such as liver failure, which can be life-threatening,
• any symptoms of infection such as fever, sore throat, or cough, as this medicine may increase the risk of serious infections, which can be life-threatening,
• coughor breathing problems, as these may indicate lung problems (interstitial lung disease or pulmonary hypertension),
• tingling, weakness, or painin the hands or feet, as these may indicate nerve problems (peripheral neuropathy).

Common side effects (may affect up to 1 in 10 people)

• mild decrease in the number of white blood cells in the blood (leucopenia),
• mild allergic reactions,
• loss of appetite, weight loss (usually insignificant),
• fatigue (asthenia),
• headache, dizziness,
• abnormal sensations in the skin such as tingling (paresthesia),
• mild increase in blood pressure,
• colitis,
• diarrhea,
• nausea, vomiting,
• mouth inflammation, mouth ulcers,
• abdominal pain,
• increase in liver test results,
• increase in hair loss,
• eczema, dry skin, skin rash, and itching (pruritus),
• tendinitis (pain caused by inflammation of the membrane surrounding the tendons, usually in the feet or hands),
• increase in certain enzyme levels in the blood (creatine phosphokinase),
• nerve problems in the arms or legs (peripheral neuropathy).

Uncommon side effects (may affect up to 1 in 100 people)

• decrease in the number of red blood cells or platelets in the blood (anemia or thrombocytopenia),
• decrease in potassium levels in the blood,
• anxiety,
• taste disturbances,
• skin rash (urticaria),
• tendon rupture,
• increase in blood fat levels (cholesterol and triglycerides),
• decrease in phosphate levels in the blood.

Rare side effects (may affect up to 1 in 1,000 people)

• increase in the number of eosinophils (a type of white blood cell) in the blood, mild decrease in the number of white blood cells in the blood (leucopenia), and decrease in the number of all blood cells (pancytopenia),
• severe increase in blood pressure,
• lung inflammation (interstitial lung disease),
• increase in liver test values that can lead to serious conditions such as hepatitis and jaundice,
• serious infections (sepsis) that can be life-threatening,
• increase in certain enzyme levels in the blood (lactate dehydrogenase).

Very rare side effects (may affect up to 1 in 10,000 people)

• significant decrease in the number of certain white blood cells in the blood (agranulocytosis),
• severe allergic reactions and potentially severe allergic reactions,
• inflammation of blood vessels (vasculitis, including necrotizing cutaneous vasculitis),
• inflammation of the pancreas (pancreatitis),
• severe liver damage such as liver failure or necrosis that can be life-threatening,
• severe reactions that can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other side effects such as kidney failure, decrease in uric acid levels in the blood, pulmonary hypertension, male infertility (this effect is reversible after stopping treatment with this medicine), cutaneous lupus (characterized by skin rash/erythema in sun-exposed areas), psoriasis (new or worsening), DRESS, and skin ulcers (round, open sores in the skin through which underlying tissues can be seen) may occur with an unknown frequency.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Leflunomida medac

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and on the blister after EXP. The expiry date is the last day of the month indicated.

Keep the bottle tightly closed to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Package contents and additional information

Composition of Leflunomida medac

• The active substance is leflunomide.

Each Leflunomida medac 10 mg film-coated tablet contains 10 mg of leflunomide.

• The other ingredients are lactose monohydrate, low-substituted hydroxypropylcellulose, tartaric acid, sodium lauryl sulfate, and magnesium stearate (E 470b) in the tablet core, as well as lecithin (soybeans), poly(vinyl) alcohol, talc, titanium dioxide (E 171), and xanthan gum in the coating.

Appearance of the product and package contents

Leflunomida medac 10 mg film-coated tablets are white to off-white, round tablets with a diameter of approximately 6 mm.

The tablets are packaged in bottles.

Leflunomida medac 10 mg film-coated tablets: They are available in pack sizes of 30, 60, or 100 film-coated tablets per bottle.

Not all pack sizes may be marketed.

Marketing authorization holder

medac

Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

Manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

medac

Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet: 07/2024

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.